After obtaining U.S. and European approvals this summer, Enable Injections has claimed its first regulatory green light in Japan for its enFuse wearable drug delivery technology. The country’s Ministry of Health, Labour and Welfare approved Sanofi’s push-button CirCLIQ Injector for administering a subcutaneous formulation of Sarclisa (isatuximab-irfc), a monoclonal antibody for multiple myeloma used in […]
Enable Injections
Inside the first-of-its-kind Enable Injections enFuse drug delivery wearable
When Sanofi won FDA approval in July 2026 for the first anticancer treatment administered with an on-body injector (OBI), the Enable Injections enFuse platform made it possible. The enFuse OBI secured its initial combination product FDA approval in 2023 for adults with paroxysmal nocturnal hemoglobinuria, a rare blood disorder. That milestone made enFuse the “first purely mechanical, large-volume, on-body […]
FDA approves Sanofi anticancer treatment delivered through Enable Injections on-body device
Sanofi announced today that the FDA approved the delivery of its Sarclisa anticancer therapy through the Enable Injections on-body device. Sarclisa (isatuximab-irfc) Escena in combination with standard-of-care regimens received clearance for the treatment of patients with multiple myeloma (MM) across all existing indications of the Sarclisa intravenous (IV) formulation. Approval makes it the first anticancer […]
Enable Injections picks up $30M investment from Sanofi
Enable Injections announced today that it received a commitment from Sanofi for a $30 million investment to drive growth. The investment from the pharmaceutical giant aims to accelerate Enable’s manufacturing build-out. It follows the company’s 2024 announcement of plans to expand its Ohio manufacturing plant. Other uses for funds include strengthening supply chain capabilities and […]
Enable Injections wins CE mark for enFuse drug delivery device
Enable Injections announced today that it received CE mark approval for its EnFuse syringe transfer system for drug delivery. enFuse, an on-body delivery system, provides subcutaneous abdominal bolus administration of drug or biologic products in accordance with the drug product requirements. The mechanical, wearable device can deliver large volumes of small molecule and biologic medications […]
Enable Injections inks deal to develop Parkinson’s therapy for delivery with EnFuse
Enable Injections announced today that it partnered with Serina Therapeutics to develop therapeutics for the enFuse delivery system. The companies aim to develop and commercialize SER-252 (POZ-apomorphine) in combination with enFuse to treat Parkinson’s disease. This deal builds upon a recent agreement that allows Roche to obtain a worldwide, exclusive license to develop and commercialize […]
Enable Injections, Roche expand enFuse delivery partnership
Enable Injections announced today that it expanded its collaboration with Roche to utilize its enFuse delivery technology in development programs. The partnership allows Roche to develop and apply Enable Injections’ expertise and enFuse technology to specific development programs. Through the collaboration, Roche can obtain a worldwide, exclusive license to develop and commercialize combinations of enFuse […]
Enable Injections to expand manufacturing facility to support drug delivery device production
Enable Injections announced today that it plans to expand its manufacturing operations with a new, large-scale facility in Ohio. In addition to the expansion in Springdale, Ohio, the company plans to enhance its corporate headquarters in Evendale, Ohio. Both facilities, nearby one another, sit just outside of Cincinnati. Enable Injections plans for its new 90,000-square-foot […]
Enable Injections promotes COO from within
Wearable drug delivery technology maker Enable Injections announced today that it named David Kroekel as its new COO. Cincinnati-based Enable develops the enFuse platform, whichallows hands-free, hidden needle drug delivery of up to 25 mL. Its simple design enables flexibility for at-home self-administration or in-clinic use. The FDA cleared the system for the delivery of […]
Enable Injections adds finance veteran to its board
Enable Injections announced today that it appointed Vickie Capps to its board of directors as the head of the audit committee. Capps joins the wearable drug delivery system maker with plenty of experience in finance and executive leadership. She also brings extensive board experience, including currently serving on the board of orthopedic company NuVasive. Other […]
